Modified Release Posaconazole in Patients With Cystic Fibrosis
1 other identifier
observational
20
1 country
1
Brief Summary
A prospective single center observational cohort of patients with cystic fibrosis to determine whether adequate serum levels of posaconazole, after administration of the newer modified release once daily oral formulation, can be achieved.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2017
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2021
CompletedOctober 26, 2020
October 1, 2020
2.9 years
December 27, 2017
October 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum levels of posaconazole in patients with cystic fibrosis taking the newer modified release once daily oral formulation.
Posaconazole serum levels at days 2, 5 and 7
7 days
Study Arms (1)
Cystic Fibrosis on Posaconazole
* Able to provide written informed consent * Greater than 18 years of age or older * Have a diagnosis of cystic fibrosis * No known azole hypersensitivity * To commence as part of their standard of care the newer modified release oral formulation of posaconazole to treat Aspergillus * Able to provide a pre-treatment sputum collected for fungal culture as part of standard of care * Have been prescribed a loading dose of 300mg bd for 1 day of the modified release posaconazole tablet followed by 300mg daily.
Interventions
A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients
Eligibility Criteria
Patients with cystic fibrosis attending care at the Alfred Hospital in Melbourne Australia
You may not qualify if:
- Known azole hypersensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
Study Sites (1)
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Related Links
Biospecimen
As standard of care a pre-treatment sputum is collected for fungal cultures. The Aspergillus isolates collected will be retained and stored frozen for future testing of posaconazole susceptibility and whole genome sequencing to characterize clonal types and virulence properties
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2017
First Posted
February 5, 2018
Study Start
March 1, 2018
Primary Completion
February 5, 2021
Study Completion
February 5, 2021
Last Updated
October 26, 2020
Record last verified: 2020-10